Recognized standard
F3334-19
FDA recognition 11-368 · ASTM · Orthopedic
Key facts
| Recognition number | 11-368 |
|---|---|
| Designation | F3334-19 |
| Title | Standard Practice for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Tibial Components |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Jul 6, 2020 |
| Device classes | Class 3, Class 2 |
| Scope (excerpt) | 1.1 This practice establishes requirements and considerations for the numerical simulation of metallic orthopaedic total knee tibial components using Finite Element Analysis (FEA) techniques for the estimation of stresses and strains. This practice is only applicable to stresses below the yield… |
At a glance
- 10–99 Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: